Trial Summary
What is the purpose of this trial?This clinical trial evaluates whether a decision aid application (app) is effective in helping breast reconstruction surgery patients make informed decisions about breast reconstruction surgery. Researchers have created a computer app for breast reconstruction surgery patients that presents images of breast reconstruction outcomes that are customized to the individual patient's treatment options and personal preferences. This decision aid app may help educate patients about how they might look after surgery and answer their questions.
Eligibility Criteria
This trial is for MD Anderson patients aged 21 or older who are planning to undergo mastectomy and immediate breast reconstruction. They must be able to stand unassisted, likely suitable for implant or abdominal-tissue based reconstruction, and read English without a translator. Excluded are those with certain psychiatric conditions, prior breast surgeries (except biopsy), planned adjuvant radiation at enrollment time, previous plastic surgery consultations for reconstruction, cognitive impairments, or tattoos on the breast.Inclusion Criteria
An MD Anderson expert thinks I'm a good fit for implant or tissue-based breast reconstruction.
I am planning to have a mastectomy, with options for skin or nipple sparing.
I am a patient at MD Anderson and I am 21 years old or older.
+3 more
Exclusion Criteria
You have a diagnosed personality disorder.
My condition is diagnosed as a type of psychosis, like schizophrenia or major depression with psychosis.
I plan to have breast reconstruction surgery at a later time.
+5 more
Participant Groups
The study tests an app designed as a decision aid for patients considering breast reconstruction surgery post-mastectomy. The app provides personalized images of potential surgical outcomes tailored to treatment options and patient preferences. It aims to assist in informed decision-making by showing how one might look after surgery.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (educational materials, enhanced consult, decision aid)Experimental Treatment4 Interventions
Patients receive newly-developed educational materials about breast reconstruction and attend an enhanced consultation visit with their plastic surgeon to discuss options for breast reconstruction surgery, during which a decision aid application containing a customized presentation of possible breast reconstruction outcomes is presented. At the end of the consultation visit, patients complete questionnaires about decision-making and psychological well-being. Within 4-6 weeks and 3-6 months after beginning the reconstruction process, patients also complete questionnaires about satisfaction with their breasts, body image, and psychological well-being, and undergo two-dimensional (2D) and 3D imaging of the torso.
Group II: Arm II (educational materials, standard of care consultation)Active Control4 Interventions
Patients receive newly-developed educational materials about breast reconstruction and attend a standard of care consultation visit with their plastic surgeon to discuss options for breast reconstruction surgery. At the end of the consultation visit, patients complete questionnaires about decision-making and psychological well-being. Within 4-6 weeks and 3-6 months after beginning the reconstruction process, patients also complete questionnaires about satisfaction with their breasts, body image, and psychological well-being, and undergo 2D and 3D imaging of the torso.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
National Institutes of Health (NIH)Collaborator